IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML
Launched by NATIONAL RESEARCH CENTER FOR HEMATOLOGY, RUSSIA · May 13, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
The IMPACT-AML clinical trial is studying the effectiveness and safety of two different treatment approaches for adults with relapsed or refractory acute myeloid leukemia (AML), a type of blood cancer that doesn't respond to standard treatments or comes back early. The trial is focused on patients who are planning to receive a specific type of stem cell transplant. Researchers want to compare high-intensity therapy to low-intensity therapy to see which option works better in helping patients recover.
To participate in this trial, you need to be at least 18 years old and diagnosed with either primary refractory AML or early relapsed AML. It's important to note that certain conditions, like having had previous stem cell transplants or other serious health issues, may prevent someone from joining. If eligible, participants can expect to receive either of the two treatment options and will be closely monitored for their response and any side effects. The trial is currently recruiting, and patients who are interested can learn more about their options by discussing it with their healthcare provider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years;
- • Primary refractory AML;
- • Early relapsed AML;
- • A signed informed consent to participate in the study.
- Exclusion Criteria:
- • Late relapsed AML;
- • Isolated extramedullary relapse;
- • MRD relapse without development of bone marrow relapse of AML;
- • Acute promyelocytic leukemia;
- • Previous refractoriness or loss of response during ongoing venetoclax therapy;
- • Previous alloHSCT;
- • Pregnancy and/or lactation period;
- • Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study;
- • Lack of signed informed consent to participate in the study;
- • Failure of the subject to follow the study protocol;
- • Participation in any other clinical trial;
- • Uncontrolled infectious complications;
- • ECOG ≥ 3;
- • History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years;
- • Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (according to the CKD-EPI Creatinine Equation);
- * Severe cardiac pathology:
- • 1. uncontrolled arterial hypertension;
- • 2. stable angina III-IV functional classes;
- • 3. unstable angina and/or myocardial infarction less than 6 months before inclusion in the study;
- • 4. heart failure stages IIb-III, NYHA functional classes III-IV
- • 5. uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities.
- • Cirrhosis classes B-C according to the Child-Pugh classification
- * Increased liver function tests above the following values:
- • 1. Total bilirubin \> 1,5 above the normal range;
- • 2. AST, ALT \> 10 above the normal range.
- • Major surgical interventions underwent less than 14 days before inclusion in the study.
About National Research Center For Hematology, Russia
The National Research Center for Hematology in Russia is a leading institution dedicated to advancing the field of hematology through innovative research and clinical trials. Established to enhance the understanding and treatment of blood disorders, the center integrates cutting-edge scientific research with clinical practice to improve patient outcomes. With a focus on collaboration and excellence, the center engages in various studies aimed at developing new therapeutic strategies, diagnostic tools, and comprehensive care approaches for hematological conditions, thereby contributing significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Moscow, , Russian Federation
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0